Background: L-asparaginase (L-ASNase) is an essential component of chemotherapy strategies due to its differential action between normal and leukemic cells. Recently, concerns about the efficiency of commercial formulations administered in developing countries have been reported, and available methods have limitations for directly determining the quality of the formulation of the medications.
Procedure:We developed a cell-based protocol to analyze the activity of different L-ASNase formulations used in Colombia to induce apoptosis of the NALM-6 cell line after 24, 48, and 72 hours, using flow cytometry. Then we compared results and determined the statistically significant differences.Results: Three statistically different groups, ranging from full to no activity against leukemic cells, using 0.05, 0.5, and 5.0 IU/ml concentrations, were identified. Group 1 (asparaginase codified [ASA]2-4) exhibited very low to no activity against B-cell acute lymphoblastic leukemia (B-ALL) cells. Group 2 (ASA6) exhibited intermediate-level activity, and group 3 (ASA1 and ASA5) exhibited high activity.Conclusions: Differences found between the therapeutic formulations of L-ASNase distributed in Colombia raise concerns about the quality of the treatment administered to patients in low-and middle-income countries. Therefore, we recommend a preclinical evaluation of formulations of L-ASNase in order to prevent therapeutical impacts on the outcome of ALL patients.
L-asparaginase (L-ASNase) is an essential component of chemotherapy
schemes due to its differential action over normal and leukemic cells.
Recently, concerns on the performance of commercial formulations
administered in developing countries have been reported. To address this
problem, we developed a cell-based protocol to compare the activity of
different L-ASNase formulations used in Colombia. We found three
statistically different groups, ranging from full to no activity on
leukemic cells using 0.05, 0.5 and 5.0 IU/mL concentrations. According
to our results, we advise a preclinical evaluation for formulations of
L-ASNase distributed in developing countries which could impact the
outcome of patients.
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